Cefotaxime (1gm)

Clinical Pharmacologist's Monograph

⚠️ Prescription Only: This medicine is Schedule H/H1. Do not self-medicate.

1. Clinical Overview

Cefotaxime is a third-generation, broad-spectrum, bactericidal cephalosporin antibiotic. It is highly effective against Gram-negative bacteria, including many beta-lactamase-producing strains, while retaining significant activity against Gram-positive organisms. It is a cornerstone of empirical therapy for serious hospital-acquired infections in India, particularly in ICU settings, due to its stability against many plasmid-mediated beta-lactamases.

OnsetDurationBioavailability
Peak serum concentrations are achieved within 30 minutes of an intravenous (IV) or intramuscular (IM) injection.The dosing interval is typically 6-12 hours for most infections, depending on severity, due to its post-antibiotic effect and time-dependent killing.Approximately 90-95% following IV administration. IM bioavailability is nearly 100% but absorption is slightly delayed.

2. Mechanism of Action

Cefotaxime is a bactericidal beta-lactam antibiotic. It inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) located inside the bacterial cell wall. This binding inhibits the final transpeptidation step of peptidoglycan synthesis, leading to the formation of a defective cell wall and ultimately to osmotic lysis and cell death.

3. Indications & Uses

  • Severe Lower Respiratory Tract Infections (Pneumonia, Lung Abscess)
  • Complicated Urinary Tract Infections (Pyelonephritis)
  • Intra-abdominal Infections (Peritonitis, Cholangitis)
  • Bacterial Septicaemia
  • Skin and Soft Tissue Infections
  • Bone and Joint Infections
  • Gonorrhoea (as a single-dose therapy)
  • Meningitis (especially in neonates and children; off-label in adults where 3rd gen cephalosporins are indicated)

4. Dosage & Administration

Adult Dosage: Moderate infections: 1gm IV/IM every 12 hours. Severe infections: 1-2gm IV every 6-8 hours. Life-threatening infections (e.g., meningitis, septic shock): Up to 2gm IV every 4 hours.

Administration: IV: Reconstitute 1gm vial with 10 mL Water for Injection. For IV bolus, administer over 3-5 minutes. For IV infusion, further dilute in 50-100 mL of compatible fluid (NS, D5W, RL) and infuse over 20-30 minutes. IM: Reconstitute with 2-3 mL of Water for Injection or 1% Lidocaine HCl (without epinephrine) to reduce pain. Inject deep into a large muscle mass. Solutions are light yellow; discard if discolored or contains particulate matter.

5. Side Effects

Common side effects may include:

  • Pain/Induration at IM injection site
  • Phlebitis/Thrombophlebitis at IV site
  • Diarrhoea (may be Clostridium difficile-associated)
  • Rash, Pruritus
  • Eosinophilia
  • Transient elevation of liver enzymes (ALT, AST)

6. Drug Interactions

DrugEffectSeverity
ProbenecidInhibits renal tubular secretion of cefotaxime, increasing and prolonging serum levels.Moderate
Aminoglycosides (e.g., Gentamicin, Amikacin)Synergistic antibacterial effect against some organisms (e.g., Pseudomonas). Increased risk of nephrotoxicity.Moderate
Potent Diuretics (e.g., Furosemide)May increase the risk of nephrotoxicity.Moderate
Oral Anticoagulants (Warfarin)May potentiate anticoagulant effect, increasing risk of bleeding.Major
ChloramphenicolAntagonistic antibacterial effect; avoid concomitant use.Major

7. Patient Counselling

  • Complete the full prescribed course even if you feel better.
  • Inform all your doctors about any allergy to penicillin or other drugs.
  • Do not share your medicine with anyone else.
  • Inform your doctor if you are pregnant, planning pregnancy, or breastfeeding.
  • For IM injection, report severe pain at the injection site.

8. Toxicology & Storage

Overdose: Symptoms of overdose are primarily neurological, including seizures, encephalopathy, and neuromuscular excitability. Nausea, vomiting, and diarrhoea may also occur.

Storage: Store unopened vials at controlled room temperature (15-25°C), protected from light and moisture. After reconstitution: For IV use, the solution in NS or D5W is stable for 24 hours at room temperature or 10 days if refrigerated (2-8°C). For IM use, use immediately after reconstitution. Do not freeze. Keep out of reach of children.